Consulting Wallah › Device Explorer › Endoscopy & surgical instruments › Endoscopic electrosurgical handpiece/electrode, bi
Device Explorer · FDA GUDID · GMDN 61817

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed

A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during e

US‑registered devices355in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Provision18352%
Suretek Medical8624%
Medline Industries, Inc.8624%

Top labelers

CompanyDevicesShare
Provision18352%
Suretek Medical8624%
Medline Industries, Inc.8624%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sustainable TechnologiesSmith and NephewStrykerDePuy MitekArthrocareArthroCareSmith & NephewMedtronicConMedArthrexVelocity OrthopedicsReprocessed Celon ProSleep Plus RFITT, 1.3mm, 0-Reprocessed Celon Probreath Bipolar RFITT, 1.1mmReprocessed Celon Probreath Bipolar RFITT, 1.1mmReprocessed Celon Prosleep Bipolar RFITT, 1.3mmReprocessed Procise Max Plasma Wand

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparosc416
GEIElectrosurgical, cutting & coagulation & accessories46
NUJElectrosurgical, cutting & coagulation accessories, laparosc25
NUJELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSC15
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES12
NLQScalpel, ultrasonic, reprocessed4

GMDN & GCC registration

  • GMDN code 61817 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 12Length (Centimeter) · 1

Use these as the dimensions to specify in a tender line.

How many endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed products are registered in the US?

355 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed", from 3 companies. The largest labeler is Provision with 52% of records.

Which FDA product codes apply?

NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparosc), GEI (Electrosurgical, cutting & coagulation & accessories), NUJ (Electrosurgical, cutting & coagulation accessories, laparosc), NUJ (ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSC)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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